JOB SUMMARY The Upstream MS&T Engineer II will apply sound scientific and engineering principles to successfully transfer and enroll new biopharmaceutical processes into the cGMP manufacturing facility. The scope of this role includes:
- Leading technical transfer projects for platform and/or repeat clinical manufacturing programs
- Supporting and/or driving business decisions and operations related to facility fit, time in plant and new technologies or equipment and communicating recommendations to the client
- Performing facility fit activities including process flow diagram generation, scaleup calculations, defining equipment and solution requirements, and generation of bill of materials (BOM) and new item specifications
- Providing technical support for cGMP production runs, CAPAs, process and product impact assessments for deviations and change controls
- Providing supervisory and technical support for cGMP production runs, deviations and process/product impact assessments, change controls, and CAPAs
- Providing supervisory and technical support during technical document execution, new equipment testing, water runs in manufacturing.
- Compiling/Collecting and analyzing process data and communicating out to the client and upper management via production updates and campaign summary reports
- Supporting/leading complex investigational and troubleshooting efforts and providing recommendations to manufacturing for implementation
- Supporting/leading collaboration on strategic projects or studies with external partners (i.e. process development, vendors) and presents results in technical reports
JOB RESPONSIBILITIES The candidate should be able to apply engineering principles in-order to problem solve and drive projects to successful completion within defined timelines. The ability to manage multiple projects and resources is required. The candidate should have the ability to work independently and with teams. The candidate should also possess excellent communication skills.
MINIMUM REQUIREMENTS
- BS in Science or Engineering with minimum of 4 years industry experience, Master’s with 2 years industry experience or PhD with no years industry experience.
- Expertise in upstream and/or downstream processing techniques and equipment in biologics
- Experience with technical transfer and scale up is required
- Experience with GMP compliance requirements
- Working knowledge of Process Development and technical knowledge supporting IND development and early phase GMP production • Experience working in a cGMP manufacturing environment is preferred
- Strong proficiency in English and overall communication is required
- Strong engineering and scientific reasoning skills are required
- Strong math skills are required
- Position requires limited physical demands
- Strong computers skills are required particularly in all MS Office programs
- Some equipment operations and testing is required
KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.
I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.
I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.
